Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

Veterans Medical Research Foundation

Status and phase: Completed; Phase 1

Conditions: Pre-diabetes

Treatments: Drug: (+)-Epicatechin

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT02330276

1R01AT008310-01 (U.S. NIH Grant/Contract)

08847

Details and patient eligibility

About

Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.

Full description

This project is a double-blinded randomized Phase I study that will include dose-ranging one day PK and pharmacodynamic (PD) studies. Subjects will include healthy individuals and subjects who meet the American Diabetes Association (ADA) criteria for pre-diabetes, including IFG.

Enrollment: 12 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy or pre-diabetic based on medical history
• Male or female
• Must be 21 to 75 years of age (inclusive)
• Able to give informed consent to the procedures
• If female, must be either postmenopausal or test negative for pregnancy at screening and on the day of the procedure. Women on estrogen therapy will be included.
• If of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
• Medication use stable for 4 weeks
• Body Mass Index (BMI) > 27 kg/m^2
• Definition of pre-diabetes: impaired fasting glucose (IFG, fasting glucose = 100-125 mg/dL) and elevated HbA1c (5.7-6.4%), each in the absence of other risk factors for diabetes

Exclusion criteria

• Type 2 diabetes
• Pregnancy
• Younger than 21 or older than 75 years of age
• Clinically significant abnormalities in liver or kidney function (>3x ULN), determined in the last 6 months by a certified clinical laboratory
• Recent MI or stroke (within 6 months of screening)
• Blood pressure (BP) >160 mmHg Systolic and >100 mmHg Diastolic
• Medications - thiazolidinediones, any steroids, anti-depressants, weight loss drugs
• Other diseases, besides type 2 diabetes, influencing carbohydrate metabolism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 3 patient groups

10 mg (+)-epicatechin

Experimental group

Description:

4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally

Treatment:

Drug: (+)-Epicatechin

30 mg (+)-epicatechin

Experimental group

Description:

4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally

Treatment:

Drug: (+)-Epicatechin

100 mg (+)-epicatechin

Experimental group

Description:

4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally

Treatment:

Drug: (+)-Epicatechin